80_FR_78382 80 FR 78141 - Bacillus Amyloliquefaciens MBI600 (Antecedent Bacillus Subtilis MBI600); Amendment to an Exemption From the Requirement of a Tolerance

80 FR 78141 - Bacillus Amyloliquefaciens MBI600 (Antecedent Bacillus Subtilis MBI600); Amendment to an Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 241 (December 16, 2015)

Page Range78141-78143
FR Document2015-31462

This regulation amends the existing exemption from the requirement of a tolerance for residues of the microbial pesticide Bacillus subtilis strain MBI600 to change the name to Bacillus amyloliquefaciens strain MBI600 (antecedent Bacillus subtilis strain MBI600) in or on all food commodities, including residues resulting from post-harvest uses, when applied or used in accordance with good agricultural practices. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to the existing exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus amyloliquefaciens strain MBI600.

Federal Register, Volume 80 Issue 241 (Wednesday, December 16, 2015)
[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Rules and Regulations]
[Pages 78141-78143]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31462]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0762; FRL-9939-54]


Bacillus Amyloliquefaciens MBI600 (Antecedent Bacillus Subtilis 
MBI600); Amendment to an Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation amends the existing exemption from the 
requirement of a tolerance for residues of the microbial pesticide 
Bacillus subtilis strain MBI600 to change the name to Bacillus 
amyloliquefaciens strain MBI600 (antecedent Bacillus subtilis strain 
MBI600) in or on all food commodities, including residues resulting 
from post-harvest uses, when applied or used in accordance with good 
agricultural practices. BASF Corporation submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an 
amendment to the existing exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of Bacillus amyloliquefaciens strain 
MBI600.

DATES: This regulation is effective December 16, 2015. Objections and 
requests for hearings must be received on or before February 16, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2008-0762, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0762 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
February 16, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2008-0762, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

[[Page 78142]]

II. Background

    In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-
00), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 4F8336) by BASF Corporation, 26 Davis Drive, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.1128 be 
amended to change the species name of the pesticide chemical substance 
covered by the existing exemption, i.e., from the microbial pesticide 
``Bacillus subtilis strain MBI600'' to ``Bacillus amyloliquefaciens 
strain MBI600 (antecedent Bacillus subtilis strain MBI600).'' The 
remaining terms of the exemption would remain the same, i.e., residues 
of the pesticide would be exempted from the requirement of a tolerance 
in or on all food commodities, including residues resulting from post-
harvest uses, when applied or used in accordance with good agricultural 
practices. That document referenced a summary of the petition prepared 
by the petitioner BASF Corporation, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
. '' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency 
consider ``available information concerning the cumulative effects of a 
particular pesticide's residues'' and ``other substances that have a 
common mechanism of toxicity.''
    EPA evaluated the available identity, toxicity and exposure data on 
Bacillus amyloliquefaciens strain MBI600 (antecedent Bacillus subtilis 
strain MBI600) and considered its validity, completeness, and 
reliability, as well as the relationship of this information to human 
risk. A full explanation of the data upon which EPA relied and its risk 
assessment based on that data can be found within the October 5, 2015, 
document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations Bacillus amyloliquefaciens strain MBI600.'' This 
document, as well as other relevant information, is available in the 
docket for this action as described under ADDRESSES. Based upon its 
evaluation, EPA concludes that there is a reasonable certainty that no 
harm will result to the U.S. population, including infants and 
children, from aggregate exposure to residues of Bacillus 
amyloliquefaciens strain MBI600. Therefore, the existing tolerance 
exemption for Bacillus subtilis strain MBI600 is amended by 
establishing an exemption from the requirement of a tolerance for 
residues of the biofungicide Bacillus amyloliquefaciens strain MBI600 
(antecedent Bacillus subtilis strain MBI600) in or on all food 
commodities, including residues resulting from post-harvest uses, when 
applied or used in accordance with good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is amending an existing exemption from the requirement of a 
tolerance without any numerical limitation for the reasons contained in 
the October 5, 2015 document entitled ``Federal Food, Drug, and 
Cosmetic Act (FFDCA) Considerations for Bacillus amyloliquefaciens 
strain MBI600.''

IV. Statutory and Executive Order Reviews

    This action amends a tolerance exemption under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S.

[[Page 78143]]

Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication of the rule in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 3, 2015.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Revise Sec.  180.1128 to read as follows:


Sec.  180.1128  Bacillus amyloliquefaciens MBI600; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biofungicide Bacillus amyloliquefaciens MBI600 
(antecedent Bacillus subtilis MBI600) in or on all food commodities, 
including residues resulting from post-harvest uses, when applied or 
used in accordance with good agricultural practices.

[FR Doc. 2015-31462 Filed 12-15-15; 8:45 am]
 BILLING CODE 6560-50-P



                                                           Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations                                                  78141

                                            ■ 4. In § 52.1521, revise the table to read                   § 52.1521       Classification of regions.
                                            as follows:                                                   *       *       *      *        *

                                                                                                                                                                   Pollutant
                                                                 Air quality control region                                 Particulate                            Nitrogen           Carbon
                                                                                                                                                Sulfur oxides                                         Ozone
                                                                                                                              matter                               dioxide           monoxide

                                            Androscoggin Valley Interstate ............................................                   IA                IA                 III              III           III
                                            Central New Hampshire Intrastate ......................................                       III               III                III              III           III
                                            Merrimack Valley—Southern New Hampshire Interstate ....                                         I                 I                III              III             I



                                            [FR Doc. 2015–31525 Filed 12–15–15; 8:45 am]                  Jefferson Clinton Bldg., Rm. 3334, 1301                  C. How can I file an objection or hearing
                                            BILLING CODE 6560–50–P                                        Constitution Ave. NW., Washington, DC                    request?
                                                                                                          20460–0001. The Public Reading Room                        Under FFDCA section 408(g), 21
                                                                                                          is open from 8:30 a.m. to 4:30 p.m.,                     U.S.C. 346a, any person may file an
                                            ENVIRONMENTAL PROTECTION                                      Monday through Friday, excluding legal                   objection to any aspect of this regulation
                                            AGENCY                                                        holidays. The telephone number for the                   and may also request a hearing on those
                                                                                                          Public Reading Room is (202) 566–1744,                   objections. You must file your objection
                                            40 CFR Part 180                                               and the telephone number for the OPP                     or request a hearing on this regulation
                                            [EPA–HQ–OPP–2008–0762; FRL–9939–54]                           Docket is (703) 305–5805. Please review                  in accordance with the instructions
                                                                                                          the visitor instructions and additional                  provided in 40 CFR part 178. To ensure
                                            Bacillus Amyloliquefaciens MBI600                             information about the docket available                   proper receipt by EPA, you must
                                            (Antecedent Bacillus Subtilis MBI600);                        at http://www.epa.gov/dockets.                           identify docket ID number EPA–HQ–
                                            Amendment to an Exemption From the                            FOR FURTHER INFORMATION CONTACT:                         OPP–2008–0762 in the subject line on
                                            Requirement of a Tolerance                                    Robert McNally, Biopesticides and                        the first page of your submission. All
                                            AGENCY:  Environmental Protection                             Pollution Prevention Division (7511P),                   objections and requests for a hearing
                                            Agency (EPA).                                                 Office of Pesticide Programs,                            must be in writing, and must be
                                                                                                          Environmental Protection Agency, 1200                    received by the Hearing Clerk on or
                                            ACTION: Final rule.
                                                                                                          Pennsylvania Ave. NW., Washington,                       before February 16, 2016. Addresses for
                                            SUMMARY:    This regulation amends the                        DC 20460–0001; main telephone                            mail and hand delivery of objections
                                            existing exemption from the                                   number: (703) 305–7090; email address:                   and hearing requests are provided in 40
                                            requirement of a tolerance for residues                       BPPDFRNotices@epa.gov.                                   CFR 178.25(b).
                                            of the microbial pesticide Bacillus                                                                                      In addition to filing an objection or
                                                                                                          SUPPLEMENTARY INFORMATION:                               hearing request with the Hearing Clerk
                                            subtilis strain MBI600 to change the
                                            name to Bacillus amyloliquefaciens                            I. General Information                                   as described in 40 CFR part 178, please
                                            strain MBI600 (antecedent Bacillus                                                                                     submit a copy of the filing (excluding
                                                                                                          A. Does this action apply to me?                         any Confidential Business Information
                                            subtilis strain MBI600) in or on all food
                                            commodities, including residues                                  You may be potentially affected by                    (CBI)) for inclusion in the public docket.
                                            resulting from post-harvest uses, when                        this action if you are an agricultural                   Information not marked confidential
                                            applied or used in accordance with                            producer, food manufacturer, or                          pursuant to 40 CFR part 2 may be
                                            good agricultural practices. BASF                             pesticide manufacturer. The following                    disclosed publicly by EPA without prior
                                            Corporation submitted a petition to EPA                       list of North American Industrial                        notice. Submit the non-CBI copy of your
                                            under the Federal Food, Drug, and                             Classification System (NAICS) codes is                   objection or hearing request, identified
                                            Cosmetic Act (FFDCA), requesting an                           not intended to be exhaustive, but rather                by docket ID number EPA–HQ–OPP–
                                            amendment to the existing exemption                           provides a guide to help readers                         2008–0762, by one of the following
                                            from the requirement of a tolerance.                          determine whether this document                          methods:
                                            This regulation eliminates the need to                                                                                   • Federal eRulemaking Portal: http://
                                                                                                          applies to them. Potentially affected
                                            establish a maximum permissible level                                                                                  www.regulations.gov. Follow the online
                                                                                                          entities may include:
                                            for residues of Bacillus                                                                                               instructions for submitting comments.
                                                                                                             • Crop production (NAICS code 111).                   Do not submit electronically any
                                            amyloliquefaciens strain MBI600.
                                                                                                             • Animal production (NAICS code                       information you consider to be CBI or
                                            DATES: This regulation is effective
                                                                                                          112).                                                    other information whose disclosure is
                                            December 16, 2015. Objections and                                                                                      restricted by statute.
                                            requests for hearings must be received                           • Food manufacturing (NAICS code
                                                                                                          311).                                                      • Mail: OPP Docket, Environmental
                                            on or before February 16, 2016, and                                                                                    Protection Agency Docket Center (EPA/
                                            must be filed in accordance with the                             • Pesticide manufacturing (NAICS                      DC), (28221T), 1200 Pennsylvania Ave.
                                            instructions provided in 40 CFR part                          code 32532).                                             NW., Washington, DC 20460–0001.
                                            178 (see also Unit I.C. of the                                                                                           • Hand Delivery: To make special
                                                                                                          B. How can I get electronic access to
                                            SUPPLEMENTARY INFORMATION).                                                                                            arrangements for hand delivery or
                                                                                                          other related information?
                                            ADDRESSES: The docket for this action,                                                                                 delivery of boxed information, please
                                            identified by docket identification (ID)                        You may access a frequently updated                    follow the instructions at http://
tkelley on DSK3SPTVN1PROD with RULES




                                            number EPA–HQ–OPP–2008–0762, is                               electronic version of 40 CFR part 180                    www.epa.gov/dockets/contacts.html.
                                            available at http://www.regulations.gov                       through the Government Printing                            Additional instructions on
                                            or at the Office of Pesticide Programs                        Office’s e-CFR site at http://                           commenting or visiting the docket,
                                            Regulatory Public Docket (OPP Docket)                         www.ecfr.gov/cgi-bin/text-                               along with more information about
                                            in the Environmental Protection Agency                        idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                     dockets generally, is available at http://
                                            Docket Center (EPA/DC), West William                          40tab_02.tpl.                                            www.epa.gov/dockets.


                                       VerDate Sep<11>2014     16:18 Dec 15, 2015     Jkt 238001    PO 00000    Frm 00023     Fmt 4700    Sfmt 4700   E:\FR\FM\16DER1.SGM   16DER1


                                            78142        Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations

                                            II. Background                                          information concerning the cumulative                 Concerning Regulations That
                                               In the Federal Register of April 6,                  effects of a particular pesticide’s                   Significantly Affect Energy Supply,
                                            2015 (80 FR 18327) (FRL–9924–00),                       residues’’ and ‘‘other substances that                Distribution, or Use’’ (66 FR 28355, May
                                            EPA issued a document pursuant to                       have a common mechanism of toxicity.’’                22, 2001) or Executive Order 13045,
                                            FFDCA section 408(d)(3), 21 U.S.C.                         EPA evaluated the available identity,              entitled ‘‘Protection of Children from
                                            346a(d)(3), announcing the filing of a                  toxicity and exposure data on Bacillus                Environmental Health Risks and Safety
                                            pesticide tolerance petition (PP 4F8336)                amyloliquefaciens strain MBI600                       Risks’’ (62 FR 19885, April 23, 1997).
                                            by BASF Corporation, 26 Davis Drive,                    (antecedent Bacillus subtilis strain                  This action does not contain any
                                            Research Triangle Park, NC 27709. The                   MBI600) and considered its validity,                  information collections subject to OMB
                                            petition requested that 40 CFR 180.1128                 completeness, and reliability, as well as             approval under the Paperwork
                                            be amended to change the species name                   the relationship of this information to               Reduction Act (PRA), 44 U.S.C. 3501 et
                                            of the pesticide chemical substance                     human risk. A full explanation of the                 seq., nor does it require any special
                                            covered by the existing exemption, i.e.,                data upon which EPA relied and its risk               considerations under Executive Order
                                            from the microbial pesticide ‘‘Bacillus                 assessment based on that data can be                  12898, entitled ‘‘Federal Actions to
                                            subtilis strain MBI600’’ to ‘‘Bacillus                  found within the October 5, 2015,                     Address Environmental Justice in
                                            amyloliquefaciens strain MBI600                         document entitled ‘‘Federal Food, Drug,               Minority Populations and Low-Income
                                            (antecedent Bacillus subtilis strain                    and Cosmetic Act (FFDCA)                              Populations’’ (59 FR 7629, February 16,
                                            MBI600).’’ The remaining terms of the                   Considerations Bacillus                               1994).
                                            exemption would remain the same, i.e.,                  amyloliquefaciens strain MBI600.’’ This                  Since tolerances and exemptions that
                                            residues of the pesticide would be                      document, as well as other relevant                   are established on the basis of a petition
                                            exempted from the requirement of a                      information, is available in the docket               under FFDCA section 408(d), such as
                                            tolerance in or on all food commodities,                for this action as described under                    the tolerance in this final rule, do not
                                            including residues resulting from post-                 ADDRESSES. Based upon its evaluation,                 require the issuance of a proposed rule,
                                            harvest uses, when applied or used in                   EPA concludes that there is a reasonable              the requirements of the Regulatory
                                            accordance with good agricultural                       certainty that no harm will result to the             Flexibility Act (RFA) (5 U.S.C. 601 et
                                            practices. That document referenced a                   U.S. population, including infants and                seq.), do not apply.
                                                                                                    children, from aggregate exposure to                     This action directly regulates growers,
                                            summary of the petition prepared by the
                                                                                                    residues of Bacillus amyloliquefaciens                food processors, food handlers, and food
                                            petitioner BASF Corporation, which is
                                                                                                    strain MBI600. Therefore, the existing                retailers, not States or tribes, nor does
                                            available in the docket, http://
                                                                                                    tolerance exemption for Bacillus subtilis             this action alter the relationships or
                                            www.regulations.gov. There were no
                                                                                                    strain MBI600 is amended by                           distribution of power and
                                            comments received in response to the
                                                                                                    establishing an exemption from the                    responsibilities established by Congress
                                            notice of filing.
                                                                                                    requirement of a tolerance for residues               in the preemption provisions of FFDCA
                                            III. Final Rule                                         of the biofungicide Bacillus                          section 408(n)(4). As such, the Agency
                                                                                                    amyloliquefaciens strain MBI600                       has determined that this action will not
                                            A. EPA’s Safety Determination
                                                                                                    (antecedent Bacillus subtilis strain                  have a substantial direct effect on States
                                               Section 408(c)(2)(A)(i) of FFDCA                     MBI600) in or on all food commodities,                or tribal governments, on the
                                            allows EPA to establish an exemption                    including residues resulting from post-               relationship between the national
                                            from the requirement for a tolerance (the               harvest uses, when applied or used in                 government and the States or tribal
                                            legal limit for a pesticide chemical                    accordance with good agricultural                     governments, or on the distribution of
                                            residue in or on a food) only if EPA                    practices.                                            power and responsibilities among the
                                            determines that the exemption is ‘‘safe.’’                                                                    various levels of government or between
                                            Section 408(c)(2)(A)(ii) of FFDCA                       B. Analytical Enforcement Methodology                 the Federal Government and Indian
                                            defines ‘‘safe’’ to mean that ‘‘there is a                 An analytical method is not required               tribes. Thus, the Agency has determined
                                            reasonable certainty that no harm will                  for enforcement purposes since the                    that Executive Order 13132, entitled
                                            result from aggregate exposure to the                   Agency is amending an existing                        ‘‘Federalism’’ (64 FR 43255, August 10,
                                            pesticide chemical residue, including                   exemption from the requirement of a                   1999) and Executive Order 13175,
                                            all anticipated dietary exposures and all               tolerance without any numerical                       entitled ‘‘Consultation and Coordination
                                            other exposures for which there is                      limitation for the reasons contained in               with Indian Tribal Governments’’ (65 FR
                                            reliable information.’’ This includes                   the October 5, 2015 document entitled                 67249, November 9, 2000) do not apply
                                            exposure through drinking water and in                  ‘‘Federal Food, Drug, and Cosmetic Act                to this action. In addition, this action
                                            residential settings, but does not include              (FFDCA) Considerations for Bacillus                   does not impose any enforceable duty or
                                            occupational exposure. Pursuant to                      amyloliquefaciens strain MBI600.’’                    contain any unfunded mandate as
                                            FFDCA section 408(c)(2)(B), in                                                                                described under Title II of the Unfunded
                                            establishing or maintaining in effect an                IV. Statutory and Executive Order
                                                                                                    Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                            exemption from the requirement of a                                                                           1501 et seq.).
                                            tolerance, EPA must take into account                      This action amends a tolerance                        This action does not involve any
                                            the factors set forth in FFDCA section                  exemption under FFDCA section 408(d)                  technical standards that would require
                                            408(b)(2)(C), which require EPA to give                 in response to a petition submitted to                Agency consideration of voluntary
                                            special consideration to exposure of                    the Agency. The Office of Management                  consensus standards pursuant to section
                                            infants and children to the pesticide                   and Budget (OMB) has exempted these                   12(d) of the National Technology
                                            chemical residue in establishing a                      types of actions from review under                    Transfer and Advancement Act
                                            tolerance and to ‘‘ensure that there is a               Executive Order 12866, entitled                       (NTTAA) (15 U.S.C. 272 note).
tkelley on DSK3SPTVN1PROD with RULES




                                            reasonable certainty that no harm will                  ‘‘Regulatory Planning and Review’’ (58
                                            result to infants and children from                     FR 51735, October 4, 1993). Because                   V. Congressional Review Act
                                            aggregate exposure to the pesticide                     this action has been exempted from                      Pursuant to the Congressional Review
                                            chemical residue. . . . ’’ Additionally,                review under Executive Order 12866,                   Act (5 U.S.C. 801 et seq.), EPA will
                                            FFDCA section 408(b)(2)(D) requires                     this action is not subject to Executive               submit a report containing this rule and
                                            that the Agency consider ‘‘available                    Order 13211, entitled ‘‘Actions                       other required information to the U.S.


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                                                          Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations                                        78143

                                            Senate, the U.S. House of                               granting of emergency exemptions                        • Pesticide manufacturing (NAICS
                                            Representatives, and the Comptroller                    under the Federal Insecticide,                        code 32532).
                                            General of the United States prior to                   Fungicide, and Rodenticide Act (FIFRA)
                                                                                                                                                          B. How can I get electronic access to
                                            publication of the rule in the Federal                  authorizing use of these pesticides. In
                                                                                                                                                          other related information?
                                            Register. This action is not a ‘‘major                  addition, the Federal Food, Drug, and
                                            rule’’ as defined by 5 U.S.C. 804(2).                   Cosmetic Act (FFDCA) requires EPA to                    You may access a frequently updated
                                                                                                    establish a time-limited tolerance or                 electronic version of 40 CFR part 180
                                            List of Subjects in 40 CFR Part 180                     exemption from the requirement for a                  through the Government Printing
                                              Environmental protection,                             tolerance for pesticide chemical                      Office’s e-CFR site at http://
                                            Administrative practice and procedure,                  residues in food that will result from the            www.ecfr.gov/cgi-bin/text-
                                            Agricultural commodities, Pesticides                    use of a pesticide under an emergency                 idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                            and pests, Reporting and recordkeeping                  exemption granted by EPA.                             40tab_02.tpl.
                                            requirements.                                           DATES: This regulation is effective
                                                                                                                                                          C. How can I file an objection or hearing
                                              Dated: December 3, 2015.                              December 16, 2015. Objections and
                                                                                                                                                          request?
                                            Robert McNally,                                         requests for hearings must be received
                                            Director, Biopesticides and Pollution                   on or before February 16, 2016, and                     Under FFDCA section 408(g), 21
                                            Prevention Division, Office of Pesticide                must be filed in accordance with the                  U.S.C. 346a, any person may file an
                                            Programs.                                               instructions provided in 40 CFR part                  objection to any aspect of this regulation
                                                                                                    178 (see also Unit I.C. of the                        and may also request a hearing on those
                                              Therefore, 40 CFR chapter I is
                                                                                                    SUPPLEMENTARY INFORMATION).                           objections. You must file your objection
                                            amended as follows:
                                                                                                    ADDRESSES: The docket for this action,                or request a hearing on this regulation
                                            PART 180—[AMENDED]                                      identified by docket identification (ID)              in accordance with the instructions
                                                                                                    number EPA–HQ–OPP–2015–0766, is                       provided in 40 CFR part 178. To ensure
                                            ■ 1. The authority citation for part 180                available at http://www.regulations.gov               proper receipt by EPA, you must
                                            continues to read as follows:                           or at the Office of Pesticide Programs                identify docket ID number EPA–HQ–
                                                Authority: 21 U.S.C. 321(q), 346a and 371.          Regulatory Public Docket (OPP Docket)                 OPP–2015–0766 in the subject line on
                                                                                                    in the Environmental Protection Agency                the first page of your submission. All
                                            ■ 2. Revise § 180.1128 to read as
                                                                                                    Docket Center (EPA/DC), West William                  requests must be in writing, and must be
                                            follows:
                                                                                                    Jefferson Clinton Bldg., Rm. 3334, 1301               received by the Hearing Clerk on or
                                            § 180.1128 Bacillus amyloliquefaciens                   Constitution Ave. NW., Washington, DC                 before February 16, 2016. Addresses for
                                            MBI600; exemption from the requirement of               20460–0001. The Public Reading Room                   mail and hand delivery of objections
                                            a tolerance.                                            is open from 8:30 a.m. to 4:30 p.m.,                  and hearing requests are provided in 40
                                              An exemption from the requirement                     Monday through Friday, excluding legal                CFR 178.25(b).
                                            of a tolerance is established for residues              holidays. The telephone number for the                  In addition to filing an objection or
                                            of the biofungicide Bacillus                            Public Reading Room is (202) 566–1744,                hearing request with the Hearing Clerk
                                            amyloliquefaciens MBI600 (antecedent                    and the telephone number for the OPP                  as described in 40 CFR part 178, please
                                            Bacillus subtilis MBI600) in or on all                  Docket is (703) 305–5805. Please review               submit a copy of the filing (excluding
                                            food commodities, including residues                    the visitor instructions and additional               any Confidential Business Information
                                            resulting from post-harvest uses, when                  information about the docket available                (CBI)) for inclusion in the public docket.
                                            applied or used in accordance with                      at http://www.epa.gov/dockets.                        Information not marked confidential
                                            good agricultural practices.                            FOR FURTHER INFORMATION CONTACT:                      pursuant to 40 CFR part 2 may be
                                            [FR Doc. 2015–31462 Filed 12–15–15; 8:45 am]            Susan Lewis, Registration Division                    disclosed publicly by EPA without prior
                                            BILLING CODE 6560–50–P                                  (7505P), Office of Pesticide Programs,                notice. Submit the non-CBI copy of your
                                                                                                    Environmental Protection Agency, 1200                 objection or hearing request, identified
                                                                                                    Pennsylvania Ave. NW., Washington,                    by docket ID number EPA–HQ–OPP–
                                            ENVIRONMENTAL PROTECTION                                DC 20460–0001; main telephone                         2015–0766 by one of the following
                                            AGENCY                                                  number: (703) 305–7090; email address:                methods:
                                                                                                    RDFRNotices@epa.gov.                                    • Federal eRulemaking Portal: http://
                                            40 CFR Part 180                                                                                               www.regulations.gov. Follow the online
                                                                                                    SUPPLEMENTARY INFORMATION:
                                            [EPA–HQ–OPP–2015–0766; FRL–9939–95]                                                                           instructions for submitting comments.
                                                                                                    I. General Information                                Do not submit electronically any
                                            Extension of Pesticide Residue                          A. Does this action apply to me?                      information you consider to be CBI or
                                            Tolerances for Emergency Exemptions                                                                           other information whose disclosure is
                                                                                                       You may be potentially affected by
                                            (Multiple Chemicals)                                                                                          restricted by statute.
                                                                                                    this action if you are an agricultural
                                            AGENCY:  Environmental Protection                       producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                            Agency (EPA).                                           pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                    list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.,
                                            ACTION: Final rule.
                                                                                                    Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                            SUMMARY:   This regulation extends                      not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                            existing time-limited tolerances for                    provides a guide to help readers                      arrangements for hand delivery or
                                            residues of the pesticides bifenthrin in                determine whether this document                       delivery of boxed information, please
                                            or on apple, peach and nectarine;                       applies to them. Potentially affected                 follow the instructions at http://
tkelley on DSK3SPTVN1PROD with RULES




                                            dinotefuran in or on pome fruit and                     entities may include:                                 www.epa.gov/dockets/contacts.html.
                                            stone fruit; imidacloprid in or on                         • Crop production (NAICS code 111).                  Additional instructions on
                                            sugarcane, cane and sugarcane                              • Animal production (NAICS code                    commenting or visiting the docket,
                                            molasses; and streptomycin in or on                     112).                                                 along with more information about
                                            grapefruit and grapefruit, dried pulp.                     • Food manufacturing (NAICS code                   dockets generally, is available at
                                            These actions are in response to EPA’s                  311).                                                 http://www.epa.gov/dockets.


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Document Created: 2015-12-16 01:01:20
Document Modified: 2015-12-16 01:01:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective December 16, 2015. Objections and requests for hearings must be received on or before February 16, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactRobert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
FR Citation80 FR 78141 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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